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NCT Number: NCT05307380

Transcultural Validation of the French Version of the Functional Pain Scale "Defense and Veterans Pain Rating Scale"

The project will validate the French translation of the "Defense and Veterans Pain Rating Scale (DVPRS)" in multiple patient types: postoperative patients, non-surgical patients with chronic pain in the context of geriatrics, palliative care, and rehabilitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Valais, Sion, Valais, Switzerland

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About this study

The primary objective of this study is to validate the French translation of the multidimensional "Defence and Veterans Pain Rating Scale" (= functional pain scale).

The hypothesis is that the functional pain scale is a valid measurement instrument for acute and chronic pain evaluation in a wide range of patient groups: postoperative patients, hospitalized patients with non-surgical pain (medical, oncological, rehabilitative, geriatric, palliative), and ambulatory chronic pain patients.

The primary endpoint is construct validity assessed as the association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale.

In addition to the association with the NRS, construct validity will be assessed by correlation of pain intensity noted on the functional pain scale intensity with the pain intensity score of the BPI for chronic pain patients, and the item "severe pain time" of the International Pain Outcomes Questionnaire (8) for postoperative patients.

Content validity will be assessed in a subgroup of patient by the association of the values for pain intensity (0-10) on the functional pain scale and the corresponding word descriptors. A factor analysis of all items of the functional pain scale will be performed.

Internal consistency of the functional pain scale will be tested by calculating Cronbach's alpha across all items.

Criterion validity will be assessed in patients for whom mobilisation is an important therapeutic goal as the discrimation between patients who can be mobilized and those who can't because of pain, and patients who consider their pain as tolerable and those who do not.

This discrimative ability will also be compared to the classical numeric rating scale, as it is a potential advantage of the functional pain scale. For the numeric rating scale, a large overlap in pain intensity for patients who consider their pain as tolerable and those who do not has been found(9).

Sensitivity to change will be evaluated by comparing values before and after an analgesic treatment for a subgroup of patients with an initial pain intensity of at least 4/10 on the functional pain scale. However, since patients with high pain levels will not be able to fill in the questionnaire, this is only an exploratory endpoint of this study.

Patient and caregiver evaluation of ease of use will also be evaluated, as well as patient judgement of tolerable pain levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acute or chronic pain, either having undergone painful surgical procedures, or having a chronic pain consultation, or being hospitalized in oncology, rehabilitative, geriatric or palliative care with painful conditions
  • French-speaking and able to understand the study information
  • ≥18 years of age

Exclusion criteria

  • Inability to understand the consent form and the questionnaire, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

Treatment and study plan

"functional pain scale"

Diagnostic Test

French translation of the Defence and Veterans Pain Rating Scale (DVPRS)

Primary outcomes

  1. construct validity for acute pain

    Time frame: immediate after inclusion

    association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale.

Secondary outcomes

  1. construct validity for chronic pain

    Time frame: immediate after inclusion

    correlation of pain intensity noted on the functional pain scale intensity with the pain intensity score of the BPI for chronic pain patients

  2. Criterion validity: ability to be mobilized

    Time frame: immediate after inclusion

    ability to be mobilized as noted by the caregiver: the patient cannot be mobilized due to pain vs. mobilisation is possible

  3. Criterion validity : pain intensity considered as tolerable

    Time frame: immediate after inclusion

    pain intensity considered as tolerable by the patient on a 0 to 10 numeric scale

  4. Sensitivity to change

    Time frame: immediate after inclusion

    comparison of values before and after an analgesic treatment for a subgroup of patients with an initial pain intensity of at least 4/10 on the functional pain scale

  5. Patient and caregiver evaluation of ease of use

    Time frame: immediate after inclusion

    Patient and caregiver evaluation of ease of use evaluated on a Likert-scale

Sponsors and collaborators

Lead sponsor

Benno Rehberg-Klug

Other

Collaborators

  • Hôpital du Valais

Registry information

Official study title

Transcultural Validation of the French Version of the Functional Pain Scale "Defense and Veterans Pain Rating Scale DVPRS"

Acronym: VALIDE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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